Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name Ocular Peg
510(k) Number K000151
Device Name PERRY-KOLBERG (PK) HA-COATED TITANIUM SLEEVE
Applicant
Integrated Orbital Implants, Inc.
4329 Graydon Rd.
San Diego,  CA  92130
Applicant Contact FLOYD G LARSON
Correspondent
Integrated Orbital Implants, Inc.
4329 Graydon Rd.
San Diego,  CA  92130
Correspondent Contact FLOYD G LARSON
Regulation Number886.3320
Classification Product Code
MQU  
Date Received01/19/2000
Decision Date 04/10/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-